Novartis’ Cosentyx Receives EU Approval for First-Line Systemic Treatment of Moderate-to-Severe Plaque Psoriasis in Children and Adolescents Aged 6–18

August 03, 2020 News /BioonBIOON/ --Novartis(Novartis) recently announced that the European Commission (EC) has approved the anti-inflammatory drug Cosentyx (Chinese brand name: Cosentyx; generic name: secukinumab, commonly known as "Su Jin Dan Kang") for the treatment of children and adolescents aged 6 to under 18 years with moderate to severe plaque psoriasis. Regarding dosage, the recommended dose for children weighing <50 kg is 75 mg (with no lower weight limit), and the recommended dose for children weighing ≥50 kg is 150 mg (initial dose 150 mg, which may be increased to 300 mg if necessary).

Compared with their peers, children with psoriasis experience a poorer quality of life due to symptoms such as pruritus and fatigue, in addition to feelings of stigma. These factors, in turn, can affect their emotional well-being and academic performance.

With this approval, Cosentyx will provide a first-line systemic therapy for the pediatric psoriasis population in Europe. Currently, Cosentyx has been approved for four indications,NovartisPlan to expand to 10 indications within the next decade.

NovartisInternational Medical AffairsImmunologyTodd Fox, Head of Hepatology and Dermatology, stated: “Psoriasis affects children far beyond the skin, leading to a deterioration in quality of life and potentially having lasting impacts on this vulnerable patient population. In the European Union, this approval marks the second for Cosentyx this year, bringing its total number of approved indications in adults to four. We are committed to reimagining care for both pediatric and adult patients.”

This approval is based on two Phase III international studies in pediatric and adolescent patients aged 6 to 18 years: an open-label, two-arm, parallel-group, multicenter study in moderate-to-severe plaque psoriasis, and a randomized, double-blind, placebo- and etanercept-controlled study in severe plaque psoriasis. These studies demonstrated that both the low dose (75–150 mg) and high dose (75–300 mg) of Cosentyx were highly effective in rapidly improving skin symptoms and quality of life, with a favorable safety profile over a period of up to 52 weeks.

In children with moderate-to-severe plaque psoriasis, low-dose Cosentyx demonstrates rapid and potent clearance of skin plaques: 93% of patients achieved a PASI 75 response (a 75% improvement from baseline in the Psoriasis Area and Severity Index) at Week 12, 69% achieved a PASI 90 response (90% improvement) at Week 12, and 88% achieved a PASI 90 response at Week 24. Furthermore, 59.5% of patients achieved complete skin clearance (PASI 100) at Week 12, and 67% achieved a PASI 100 response at Week 24. In patients with severe psoriasis, low-dose Cosentyx ensured sustained skin clearance through Week 52, with 75% of patients achieving a PASI 90 response. Differences in PASI 75 response were observed as early as Week 4 in patients with severe psoriasis and as early as Week 2 in those with moderate-to-severe psoriasis.

Based on the Children’s Dermatology Life Quality Index (CDLQI) 0/1 response, half of children with moderate-to-severe plaque psoriasis achieved complete relief from the symptom burden of psoriasis before Week 12. Among children with severe plaque psoriasis treated with a low dose of Cosentyx, 44.7% of patients achieved complete clearance at Week 12, and 60.6% at Week 52. The safety profiles of both low-dose and high-dose Cosentyx were similar to and consistent with those established in adult psoriasis indications. No new safety signals were observed in the pediatric population.

Psoriasis is a lifelong, systemic inflammatory disease that significantly impacts patients’ physical and emotional quality of life. One-third of psoriasis cases begin in childhood, with onset most commonly occurring during adolescence. Moderate-to-severe psoriasis affects more than 350,000 children worldwide and can have “profound effects beyond the skin,” as the physiological and psychological burden of psoriasis disrupts critical developmental periods. Between 1970 and 2000, the incidence of pediatric psoriasis in the United States more than doubled, and rising incidence trends have been reported in multiple countries. With only a few approved treatment options available, unmet medical needs remain high.

Cosentyx is the first fully human monoclonal antibody drug that specifically targets and inhibits interleukin-17A (IL-17A). It can selectively block the activity of circulating IL-17A, reduce immune system activity, and improve disease symptoms. Studies have revealed that IL-17A drives the body in multipleAutoimmunityplay a crucial role in the immune response of spondyloarthropathies, including psoriatic arthritis (PsA), plaque psoriasis (PsO), ankylosing spondylitis (AS), and non-radiographic axial spondyloarthritis (nr-axSpA).

Cosentyx was approved for market launch in January 2015 and has currently received approval for four indications (PsO, PsA, AS, and nr-axSpA). Cosentyx is supported by robust clinical evidence, including 5-year data for the top three indications (PsO, PsA, and AS), as well as real-world evidence. These data reinforce the unique position of Cosentyx as a rapid and durable comprehensive treatment option across axSpA, PsA, and psoriasis. Since its launch, more than 340,000 patients worldwide have been treated with Cosentyx.

In China, Cosentyx® (Cosentyx) was approved by the National Medical Products Administration (NMPA) in late April this year for adult patients with ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. This marks the second indication for Cosentyx® in China, following its approval in March 2019 for the treatment of moderate-to-severe plaque psoriasis (PsO), and it is currently the first and only interleukin inhibitor approved in the country for the treatment of ankylosing spondylitis (AS).

In mid-June, Cosentyx® (Secukinumab) Sensoready® Pen was approved in China. As an upgraded version of the Cosentyx® pre-filled syringe, the Cosentyx® Sensoready® Pen comprehensively optimizes the original administration method. Its "one-touch" operation reduces injection difficulty and enhances patient treatment experience, while effectively minimizing drug waste caused by operational errors. This brings a more convenient, safe, and efficient new treatment experience to the vast number of Chinese patients with moderate-to-severe plaque psoriasis and ankylosing spondylitis. (Bioon.com)

Original source: Novartis Cosentyx® receives EUapproval for first-line systemic treatment in pediatric psoriasis